-- Interferon- and Ribavirin-Free Therapy Effective against
Genotype 1 HCV, Japan's Most Prevalent Strain of the Disease --
-- Japanese Regulatory Submission for Ledipasvir/Sofosbuvir
Anticipated by Year End --
FOSTER CITY, Calif.--(BUSINESS WIRE)--
Gilead Sciences, Inc. (Nasdaq:GILD) today announced topline results
from a Phase 3 clinical trial (GS-US-337-0113) in Japan evaluating the
investigational once-daily fixed-dose combination of the NS5A inhibitor
ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor
sofosbuvir (SOF) 400 mg, with and without ribavirin (RBV), for the
treatment of genotype 1 chronic hepatitis C virus (HCV) infection. Among
patients receiving 12 weeks of LDV/SOF without RBV, 100 percent
(n=83/83) of treatment-naïve and 100 percent (n=88/88) of
treatment-experienced patients achieved a sustained virologic response
12 weeks after completing therapy (SVR12). Among patients receiving
LDV/SOF plus RBV, 96 percent (n=80/83) of treatment-naïve and 100
percent of treatment-experienced patients (n=87/87) achieved SVR12.
Across all arms of the study, patients with cirrhosis achieved a 99
percent (n=75/76) SVR12. The study met its primary endpoint of
superiority compared to a predefined historical SVR12 rate. Patients who
achieve SVR12 are considered cured of HCV infection.
Genotype 1 is the most common strain of HCV in Japan, accounting for
approximately 70 percent of the more than one million people chronically
infected with the disease. The majority of these infections are due to
HCV genotype 1b. Current treatment options for genotype 1 HCV infection
involve up to 48 weeks of therapy with pegylated interferon injections,
RBV tablets and other oral medicines, which may not be suitable for
"The cure rates observed with LDV/SOF in this study are impressive
because they were achieved without the need for interferon or ribavirin,
both of which involve more complex dosing requirements and may be
associated with significant side effects," said Norbert Bischofberger,
PhD, Gilead's Executive Vice President of Research and Development and
Chief Scientific Officer. "These results suggest that a once-daily
LDV/SOF tablet has the potential to be an efficacious and well-tolerated
regimen for many HCV patients in Japan."
In the study, 341 patients with genotype 1 HCV infection were randomized
(1:1) to receive 12 weeks of all-oral therapy with LDV/SOF, with or
without RBV. Of these, 166 patients were treatment-naïve, 175 were
treatment-experienced and 76 had compensated cirrhosis. The
intent-to-treat SVR12 rates in the study are summarized in the table
Genotype 1 treatment-naïve
LDV/SOF + RBV
Genotype 1 treatment-experienced
LDV/SOF + RBV
Overall, 338/341 patients (99 percent) in Study GS-US-337-0113 achieved
SVR12. Of the three patients who failed to achieve SVR12, one patient
relapsed after discontinuation of therapy, one patient discontinued
therapy after one week of treatment due to rash and one patient died
during the study.
Fewer adverse events were observed in the RBV-free arms compared to the
RBV-containing arms in the study, most notably with regard to anemia,
which was observed in 14 percent of patients taking LDV/SOF plus RBV
compared to 2 percent of patients receiving LDV/SOF alone. Adverse
events observed with LDV/SOF without RBV were generally mild and
included nasopharyngitis (28 percent), headache (6 percent) and malaise
(5 percent). Among those taking LDV/SOF plus RBV, in addition to anemia,
the most common adverse events were nasopharyngitis (22 percent),
pruritus (8 percent), rash (8 percent), headache (8 percent), stomatitis
(6 percent), nausea (5 percent) and malaise (5 percent). No patients
taking LDV/SOF and two patients taking LDV/SOF plus RBV discontinued
treatment due to treatment-emergent adverse events. Full study results
will be presented at a future scientific meeting.
Based on these data, Gilead plans to submit a New Drug Application for
the LDV/SOF fixed-dose combination with the Japanese Pharmaceutical and
Medical Devices Agency (PMDA) by the end of 2014. The product is
currently under regulatory review in the United States and European
On April 2, 2014, Gilead announced topline results from another Phase 3
study in Japan evaluating SOF as a single agent in combination with RBV
for the treatment of genotype 2 HCV infection. The company plans to file
for approval of SOF with the PMDA by mid-2014. SOF as a single agent has
been approved by regulatory authorities in the United States, European
Union and Canada under the tradename Sovaldi®.
LDV/SOF and SOF are investigational products in Japan and their safety
and efficacy have not yet been established.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical
need. The company's mission is to advance the care of patients suffering
from life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North and South America, Europe and
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable results from additional clinical trials
involving SOF or the LDV/SOF fixed-dose combination in Japan and the
possibility that the company may not file for regulatory approval of SOF
as a single agent or the LDV/SOF fixed-dose combination in Japan in the
currently anticipated timelines. Further, the PDMA and regulatory
authorities in the United States and the European Union may not approve
the LDV/SOF fixed-dose combination and the PMDA may not approve SOF as a
standalone agent in Japan, and any marketing approvals, if granted, may
have significant limitations on their use. These risks, uncertainties
and other factors could cause actual results to differ materially from
those referred to in the forward-looking statements. The reader is
cautioned not to rely on these forward-looking statements. These and
other risks are described in detail in Gilead's Quarterly Report on Form
10-Q for the quarter ended March 31, 2014, as filed with the U.S.
Securities and Exchange Commission. All forward-looking statements are
based on information currently available to Gilead, and Gilead assumes
no obligation to update any such forward-looking statements.
U.S. full prescribing information for Sovaldi is available at www.gilead.com.
Sovaldi is a registered trademark of Gilead Sciences, Inc.
For more information on Gilead Sciences, please visit the company's
website at www.gilead.com,
follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs
at 1-800-GILEAD-5 or 1-650-574-3000.
Source: Gilead Sciences, Inc.